To Evaluate Safety & Immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 for COVID-19 in Healthy Adults Received 2 Doses of BNT162b2

NCT05200741 | Unknown Phase 2

• 1 other identifier: CTC2235
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and immunogenicity of DelNS1-2019-nCoV-RBD-OPT1 as booster vaccine for COVID-19 in healthy adults who have received 2 doses of BNT162b2

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• Reactogenicity

  Occurrence of solicited local events (nasal irritation, sneezing, nasal congestion, cough, sore throat, change in smell, change in taste, change in vision and eye pain) and solicited systemic events (fever, headache, malaise, myalgia, joint pain, nausea, vomiting, diarrhea, abdominal pain, chills and sweating) for a 14-day period after each vaccination

  Day 1 to 15 and Day 22 to 36

• Adverse Events

  Occurrence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

  Day 1 to Day 202(±7)

• Neutralizing Antibodies in Serum against Live SARS-CoV-2 Measured by Neutralization Assay

  Measurement of neutralizing antibody levels by microneutralization (MN) assay in serum samples

  Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)

• Binding Antibodies in Serum against SARS-CoV-2 RBD Measured by CMIA

  Measurement of binding antibody responses by chemiluminescent microparticle immunoassay (CMIA) in serum samples

  Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)

Secondary Outcomes (2)

• T-cell Responses against SARS-CoV-2 Spike Peptide Measured by ELISpot

  Day 1(pre-dose), 22(pre-dose), 36(+2) and 50(±3)

• Total Ig Antibodies in Mucosal Secretion against SARS-CoV-2 RBD Measured by ELISA

  Day 1(pre-dose), 4(+1), 22(pre-dose), 25(+1), 36(+2) and 50(±3)

Study Arms (2)

Test Product

EXPERIMENTAL

DelNS1-2019-nCoV-RBD-OPT1 virus titre at not less than 6.3 lg CCID50/dose, 2 doses 3 weeks apart, intranasal administration

Biological: DelNS1-2019-nCoV-RBD-OPT1

Reference Product

PLACEBO COMPARATOR

Matching placebo, 2 doses 3 weeks apart, intranasal administration

Biological: Matching placebo

Interventions

DelNS1-2019-nCoV-RBD-OPT1 BIOLOGICAL

Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray

Test Product

Matching placebo BIOLOGICAL

Solution for Intranasal Spray

Reference Product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an ICF indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.
• BNT162b2 Vaccination Status: The subject must have received 2 doses of BNT162b2 in Hong Kong, with the second dose completed at least 180 days prior to the first vaccination.
• Gender and Age: Male or female, at the age of ≥ 18 and ≤ 75 on the day of signing the ICF.
• Body Weight and BMI: Body weight ≥ 45 kg and BMI ≥ 18.5 kg/m2 and \< 25 kg/m2 at screening and baseline.
• Medical Conditions or Diagnoses: Existence of all of the following medical conditions or diagnoses:
• Generally in good health with no clinically significant abnormality, as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests at screening and baseline;
• Normal vital signs at screening and baseline, as defined by:
• Body (tympanic) temperature ≤ 37.5 oC;
• Resting pulse rate ≥ 50 and ≤ 100 bpm; and
• DBP ≥ 50 and ≤ 90 mmHg and SBP ≥ 90 and ≤ 140 mmHg.
• Contraception: Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s) as detailed below:
• A female subject who is a woman of childbearing potential (WOCBP) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from at least 30 days prior to the first vaccination until 60 days after the second vaccination;
• A male subject (i) who is sexually active with a WOCBP (except who is permanently sterile by bilateral orchiectomy or vasectomy) must be willing and agree to remain abstinent or practise at least one effective contraceptive method from the first vaccination until 60 days after the second vaccination; and (ii) must be willing and agree to refrain from sperm donation during the aforesaid period.
• Breastfeeding: A female subject must be willing and agree to avoid engagement in breastfeeding at any time from the first vaccination until 60 days after the second vaccination.
• Blood Donation: Willingness and agreement to avoid blood donation from screening to the end of the period of participation in this study.

You may not qualify if:

• Medical History: History of any of the following diseases or conditions:
• COVID-19;
• SARS;
• Any significant respiratory diseases (e.g. COPD, asthma);
• Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
• Blood dyscrasias or any significant disorder of coagulation;
• Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
• Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
• Any malignant neoplastic disease;
• Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
• Any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation;
• Any immunodeficiency or autoimmune disease;
• Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care;
• Any nasal septal defect, cleft palate, nasal polyps or other nasal abnormality that might affect vaccine administration;
• History of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKU Phase 1 Clinical Trials Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

• Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray (DelNS1-2019-nCoV-RBD-OPT1) Phase III Clinical Trial - Investigator's Brochure (Version 2.0, Dated 02-Sep-2021).

  BACKGROUND

• Wang P, Zheng M, Lau SY, Chen P, Mok BW, Liu S, Liu H, Huang X, Cremin CJ, Song W, Chen Y, Wong YC, Huang H, To KK, Chen Z, Xia N, Yuen KY, Chen H. Generation of DelNS1 Influenza Viruses: a Strategy for Optimizing Live Attenuated Influenza Vaccines. mBio. 2019 Sep 17;10(5):e02180-19. doi: 10.1128/mBio.02180-19.

  PMID: 31530680 BACKGROUND

• Zheng M, Wang P, Song W, Lau SY, Liu S, Huang X, Mok BW, Liu YC, Chen Y, Yuen KY, Chen H. An A14U Substitution in the 3' Noncoding Region of the M Segment of Viral RNA Supports Replication of Influenza Virus with an NS1 Deletion by Modulating Alternative Splicing of M Segment mRNAs. J Virol. 2015 Oct;89(20):10273-85. doi: 10.1128/JVI.00919-15. Epub 2015 Jul 29.

  PMID: 26223635 BACKGROUND

Related Links

• Accessed on 15 November 2021
• Accessed on 15 November 2021
• Accessed on 07 January 2021
• Accessed on 15 November 2021

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ivan Fan-ngai Hung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volunteer Resource Centre

CONTACT

85296812309; ctcvrc@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 21, 2022
• Study Start: February 8, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)